Appeal No. 2004-0250 Page 12
Application No. 09/226,412
helpful in any Rule 608(b) showing if appellants provide evidence in support of the
assertion that they were diligent in their pursuit of a reduction to practice. Given the
relatively short time period between March 27, 1997 and April 18, 1997, a day-by-day
accounting of the alleged diligent activity would be helpful.
New Grounds of Rejection Based Upon Gonda ‘250
Claims 30, 31, 32, 34-46, and 48 are rejected under 35 U.S.C. § 102(e) as
anticipated by Gonda ‘250.
Turning first to claim 30, we find that claim 30 is directed to a method of
administering a monomeric insulin analog to a patient in need thereof by “pulmonary
means.” The monomeric insulin analog required by claim 30 is selected from a
Markush group which includes modified human insulins wherein the amino acid residue
at position B28 is substituted with Lys and the amino acid residue at position B29 is
Pro, i.e., Lyspro. The other requirement of claim 30 is that the monomeric insulin
analog be inhaled through the mouth of the patient.
Considering first the requirement of claim 30 that the monomeric insulin analog
be administered to the patient by “pulmonary means,” we note in Unidynamics v.
Automatic Prod. Int’l, 157 F.3d 1311, 1319, 48 USPQ2d 1099, 1104 (Fed. Cir. 1998)
(citation omitted) the court stated that “[t]he use of the term ‘means’ generally (but not
always) shows that the patent applicant has chosen the option of means-plus-function
format invoking § 112, ¶ 6 construction.” As set forth in 35 U.S.C. § 112, sixth
paragraph, if a claim limitation invokes this section of the statute, it must be interpreted
to cover the corresponding structure, materials, or acts in the specification and
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